H.R. 1262 · 119th Congress

Mikaela Naylon Give Kids a Chance Act

Introduced on Feb 12, 2025 by Michael T. McCaul (R-TX-10). 313 cosponsors, 180 of them from another party. Latest action (Dec 2, 2025): Received in the Senate.

Stage
Passed one chamber
Introduced
Feb 12, 2025
Cosponsors
313
180 from the other party
Policy area
Health
Open in the Congress explorerCongress.govAlert me

Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. Reported by committee
  3. Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.

Subjects

  • Arab-Israeli relations
  • Bahrain
  • Cancer
  • Child health
  • Computers and information technology
  • Congressional oversight
  • Drug safety, medical device, and laboratory regulation
  • Executive agency funding and structure
  • Food and Drug Administration (FDA)
  • Government information and archives
  • Government studies and investigations
  • Health information and medical records
  • International law and treaties
  • Israel
  • Licensing and registrations
  • Medical research
  • Organ and tissue donation and transplantation
  • Performance measurement
  • Prescription drugs
  • Research administration and funding
  • Telephone and wireless communication
  • United Arab Emirates
  • User charges and fees

Summary

By the Congressional Research Service (Introduced in House, Feb 12, 2025). Public domain.

Give Kids a Chance Act of 2025

This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research.

Specifically, the bill

  • modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs in combination with active ingredients that have already been approved, provided certain conditions are met;
  • permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirement;
  • renews the FDA’s authority to award priority review vouchers to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029; and
  • reauthorizes through FY2027 certain funding for the National Institutes of Health to support priority pediatric research.

The bill also provides statutory authority for the FDA’s interpretation of the orphan drug exclusivity period. The bill specifies, consistent with FDA regulations, that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drugs) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. (In Catalyst Pharmaceuticals, Inc. v. Becerra, a court rejected the FDA’s interpretation and held that orphan drug exclusivity extends to all uses or indications for the disease or condition.)

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Michael T. McCaulR-TX-10Sponsor

Democrats · 180

Independents · 1

Republicans · 132

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Feb 12, 2025Introduced in House
  2. Feb 12, 2025Introduced in House
  3. Feb 12, 2025 · HouseReferred to the House Committee on Energy and Commerce.
  4. Sep 17, 2025 · HouseCommittee Consideration and Mark-up Session Held
  5. Sep 17, 2025 · HouseOrdered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
  6. Oct 31, 2025Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
  7. Oct 31, 2025 · HouseReported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
  8. Oct 31, 2025 · HousePlaced on the Union Calendar, Calendar No. 304.
  9. Dec 1, 2025 · HouseMr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
  10. Dec 1, 2025 · HouseConsidered under suspension of the rules. (consideration: CR H4929-4935)
  11. Dec 1, 2025 · HouseDEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
  12. Dec 1, 2025Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
  13. Dec 1, 2025 · HouseOn motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
  14. Dec 1, 2025 · HouseMotion to reconsider laid on the table Agreed to without objection.
  15. Dec 2, 2025 · SenateReceived in the Senate.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. BIOTECHNOLOGY INNOVATION ORGANIZATION15 reports
    $7.2M reported (all issues)
  2. IONIS PHARMACEUTICALS, INC.11 reports
    $760K reported (all issues)
  3. PTC THERAPEUTICS, INC.10 reports
    $1M reported (all issues)
  4. STEALTH BIOTHERAPEUTICS INC.10 reports
    $620K reported (all issues)
  5. ACADIA PHARMACEUTICALS9 reports
    $3.1M reported (all issues)
  6. ALLIANCE FOR REGENERATIVE MEDICINE9 reports
    $790K reported (all issues)
  7. Travere Therapeutics9 reports
    $1.1M reported (all issues)Federal contractor: TRAVERE THERAPEUTICS, INC.$323.9K in contracts, FY2026AI match · 100%
  8. HealthCare Institute of New Jersey7 reports
    $333.2K reported (all issues)
  9. PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA7 reports
    $57.5M reported (all issues)
  10. Biotechnology Innovation Organization (BIO)6 reports
    $360K reported (all issues)
  11. Dana-Farber Cancer Institute6 reports
    $379.7K reported (all issues)Federal contractor: DANA-FARBER CANCER INSTITUTE, INC.$933K in contracts, FY2026AI match · 100%
  12. NOVARTIS CORPORATION6 reports
    $13.1M reported (all issues)Federal contractor: NOVARTIS PHARMACEUTICALS CORPORATION$36.2M in contracts, FY2026AI match · 100%
  13. RARE DISEASE COMPANY COALITION6 reports
    $460K reported (all issues)
  14. ASSOCIATION FOR CLINICAL ONCOLOGY5 reports
    $1.3M reported (all issues)
  15. AstraZeneca Pharmaceuticals LP5 reports
    $7.4M reported (all issues)Federal contractor: ASTRAZENECA PHARMACEUTICALS LP$500 in contracts, FY2026AI match · 100%
  16. BRIDGEBIO PHARMA INC.5 reports
    $1.6M reported (all issues)
  17. Bayer Corporation (consolidated report)5 reports
    $11.2M reported (all issues)
  18. EVERYLIFE FOUNDATION FOR RARE DISEASES5 reports
    $220K reported (all issues)
  19. INCYTE CORPORATION5 reports
    $2.1M reported (all issues)
  20. ULTRAGENYX PHARMACEUTICAL INC.5 reports
  21. American Cancer Society Cancer Action Network, Inc.4 reports
    $9.1M reported (all issues)
  22. Astria Therapeutics, Inc.4 reports
    $160K reported (all issues)
  23. BIOMARIN PHARMACEUTICAL INC.4 reports
    $1.3M reported (all issues)
  24. CHIESI USA, INC.4 reports
  25. Cystic Fibrosis Foundation4 reports
    $760K reported (all issues)
  26. GSK (fka GLAXOSMITHKLINE INC.)4 reports
    $4.1M reported (all issues)
  27. NATIONAL ASSOCIATION OF CHILDREN'S HOSPITALS (N.A.C.H.)4 reports
    $6.1M reported (all issues)
  28. National Brain Tumor Society4 reports
    $80K reported (all issues)
  29. ORCHARD THERAPEUTICS NORTH AMERICA4 reports
    $1.2M reported (all issues)
  30. SOLENO THERAPEUTICS, INC.4 reports
    $200K reported (all issues)
  31. Aquestive Therapeutics3 reports
    $180K reported (all issues)
  32. Blood Cancer United (FKA The Leukemia & Lymphoma Society)3 reports
    $860K reported (all issues)
  33. Campaign for Sustainable Drug Pricing (CSRxP)3 reports
    $150K reported (all issues)
  34. Epilepsy Foundation3 reports
    $210K reported (all issues)
  35. Fortress Biotech Inc.3 reports
    $40K reported (all issues)
  36. HARMONY BIOSCIENCES, LLC3 reports
    $510K reported (all issues)Federal contractor: HARMONY BIOSCIENCES LLC$614.4K in contracts, FY2026AI match · 100%
  37. LUNDBECK LLC3 reports
    $440K reported (all issues)Federal contractor: LUNDBECK LLCAI match · 99%
  38. NATIONWIDE CHILDREN'S HOSPITAL, INC.3 reports
    $350K reported (all issues)
  39. National Health Council3 reports
    $59.7K reported (all issues)
  40. Rafael Holdings, Inc.3 reports
    $72K reported (all issues)

Reports filed in 2025, 2026.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 9, 2026 · loaded Oct 9, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 9, 2026 · loaded Oct 9, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.